(99 days)
The NuVasive® X-Core® Mini Cervical Expandable VBR System is a vertebral body replacement device indicated for use in the cervical spine (C3-C7 vertebral bodies) in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The NuVasive® X-Core® Mini Cervical Expandable VBR System is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine.
These implants are intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion. The NuVasive® X-Core® Mini Cervical Expandable VBR System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
The X-Core® Mini Cervical Expandable VBR System is manufactured from Ti-6A1-4V ELI conforming to ASTM F136 and ISO 5832-3. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. This 510(k) is to expand the indications for use of NuVasive® X-Core® Mini Expandable VBR System (K142205) to include treatment of tumors, trauma, and degenerative disorders of the cervical spine.
This document describes the 510(k) premarket notification for the NuVasive® X-Core® Mini Cervical Expandable VBR System. Based on the provided text, a detailed breakdown of acceptance criteria and the study proving the device meets them cannot be fully constructed as this type of information is typically found in a clinical study report or a more detailed biocompatibility/performance report, which is not present in this 510(k) summary.
However, I can extract the information available from the provided text regarding the device's comparison to predicate devices and the nature of the data provided.
1. A table of acceptance criteria and the reported device performance
The provided 510(k) summary does not explicitly state quantitative acceptance criteria in a table format nor does it present device performance against such criteria. Instead, it relies on demonstrating substantial equivalence to predicate devices based on design, intended use, performance, material composition, and function.
The key claim of performance is that the "NuVasive® X-Core® Mini Cervical Expandable VBR System used in the treatment of tumors, trauma, and degenerative disorders of the cervical spine has a safety and effectiveness profile that is similar to the predicate device."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "clinical literature review and retrospective clinical data analysis." It does not specify a sample size for this retrospective analysis or the clinical literature. It also does not specify the country of origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the 510(k) summary. "Clinical literature review and retrospective clinical data analysis" suggests reliance on existing published and recorded clinical observations, but the specific process for establishing ground truth or involvement of independent experts is not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This device is a physical implant (vertebral body replacement system), not an AI/software device that assists human readers. Therefore, an MRMC comparative effectiveness study involving AI assistance is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a physical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document mentions "clinical literature review and retrospective clinical data analysis" to support the "safety and effectiveness profile." This implies that the ground truth for the "safety and effectiveness profile" would be based on observed patient outcomes and clinical assessments from the literature and retrospective data, rather than a single type like pathology or expert consensus from a new study.
8. The sample size for the training set
The document does not describe a "training set" as this is not a machine learning device. The basis for comparison is "published clinical literature review and retrospective clinical data analysis" related to existing systems.
9. How the ground truth for the training set was established
This question is not applicable as the device is a physical implant and not an AI/machine learning device. The "ground truth" for its functional and safety profile is based on the performance of the predicate devices and the clinical evidence gathered through retrospective analysis and literature review.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.